At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Your Role: Regulatory Affairs Lead - South Asia
As a Regulatory Affairs Lead, you will spearhead the registration and lifecycle management of Elanco’s diverse portfolio across India and South Asia. In this role, you will navigate complex regulatory landscapes to ensure our products reach the animals and owners who need them most while maintaining 100% compliance.
Your Responsibilities:
Lead end-to-end registration for new drugs, biologicals, and pharmaceuticals across India and South Asian markets (Sri Lanka, Bangladesh, and Nepal).
Compile and review high-quality Chemistry, Manufacturing, and Controls (CMC) data, ensuring all registration files meet rigorous international and local standards.
Drive operational efficiency through expert use of online portals such as SUGAM and NSWS to ensure seamless submissions and rapid approvals.
Provide critical Pharmacovigilance (PV) stewardship for the region, overseeing PSUR filings and AEPC reporting while maintaining strict SOP compliance.
Build and maintain strong professional relationships with health authorities including CDSCO, State FDAs, DAHD, and AQCS.
What You Need to Succeed (minimum qualifications):
Education: BVSc & AH, B. Pharm / M. Pharm, or M.Sc. in Life Sciences
Experience: Minimum 8 years of focused regulatory experience within a multinational pharmaceutical company, specifically within the Veterinary/Animal Health sector
Top skills: Advanced proficiency in regulatory portals (SUGAM, NSWS) and expert-level understanding of the Drugs & Cosmetics Act and CDSCO guidelines
What will give you a competitive edge (preferred qualifications):
Master’s degree in Life Sciences or a related field
Proven ability to translate complex regulatory requirements into actionable business plans for cross-functional teams
Strong background in managing regional oversight for Sri Lanka, Bangladesh, and Nepal
Experience in artwork and labelling compliance and coordinating essential certifications (ML, NCC, GMP, FSC)
Demonstrated proactive leadership with the ability to manage multiple high-priority tasks in a fast-paced environment
Additional Information:
Location: India Mumbai
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
